evaluation of igm-6268 in healthy adults and patients with mild to moderate covid-19

Conditions: Healthy Volunteers; COVID-19

Summary: this is a phase 1, multi-center, randomized, double-blinded, placebo-controlled study to assess the safety, tolerability, and pharmacokinetics (pk) of igm-6268 administered intranasally and intraorally in healthy volunteers and in outpatients with mild-moderate covid-19. igm-6268 or placebo will be administered by intranasal + intraoral spray using a teleflex mucosal atomization device nasal™ intranasal mucosal atomization device once, or once or twice each day for 5 days.

igm-6268 is an engineered immunoglobulin m (igm) antibody that specifically targets the receptor binding domain (rbd) of the sars-cov-2 spike protein. this humanized pentameric igm antibody has 10 binding sites to the spike protein and a j-chain to enable the formation of igm pentamers. igm-6268 is being developed as a treatment for or prophylaxis of symptoms associated with mild to moderate covid-19. the primary mechanism of action of igm-6268 is to block the binding of the sars-cov-2 rbd on the spike protein to human angiotensin converting enzyme 2 (hace2), the cellular receptor for sars-cov-2. by blocking this binding, igm 6268 neutralizes the infectivity of the virus.

Eligibility criteria:
healthy volunteers inclusion criteria: * is male or non-pregnant female adult ≥ 18 and ≤ 55 years of age * has a body mass index (bmi) \< 35 kg/m2. * is healthy as determined by medical history and physical examination * agrees to use contraception through 3 months after the last dose of igm-6268 exclusion criteria: * receipt of any covid-19 vaccine during this study and follow-up period * prior positive sars-cov2 test * hepatitis b virus (hbv), hepatitis c virus (hcv), or uncontrolled human immunodeficiency virus (hiv) infection * use of any nasally administered drug mild-moderate covid patients inclusion criteria: * is male or non-pregnant female adult ≥ 18 and ≤ 55 years of age * agrees to use contraception through 3 months after the last dose of igm-6268 * agrees to the collection of blood, urine, saliva, and nasopharyngeal samples, per protocol. * signs and symptoms of mild to moderate covid-19 but not requiring hospitalization * has a laboratory-confirmed sars-cov-2 infection as determined by fda-authorized antigen or naat diagnostic assay during the period of 72 hours prior to enrollment. exclusion criteria: * receipt of any covid-19 vaccine during this study and follow-up period * receipt of remdisivir, antiviral antibody treatment (plasma or mabs), immosuppressive therapies, or cytokine-targeted anti-inflammatory drugs * concurrent use of drugs not approved for use in covid-19 patients (e.g., ivermectin, chloroquine/hydroxychloroquine, budesonide). * co-morbidities including but not limited to hypertension, cardiovascular disease, diabetes (type 1 or 2), chronic kidney disease, or asthma * subject is considered to be in their last few weeks of life prior to this acute illness * cancer within the last 5 years except stable prostate cancer and basal cell carcinoma * hepatitis b virus (hbv), hepatitis c virus (hcv), or uncontrolled human immunodeficiency virus (hiv) infection * influenza or confirmed or suspected pulmonary or systemic bacterial infection * receipt of any covid-19 vaccine during this study and follow-up period * use of any nasally administered drug